Copaxone 3 Times Weekly Safe, Effective for Ambulatory Patients With Relapsing MS
Participants showed a significant decrease in annual relapse rate and a significant improvement in both patient-reported disability scores and information processing scores.
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There is real-world evidence that Copaxone® 40 mg 3 times a week is safe, tolerable, and effective for ambulatory patients with relapsing multiple sclerosis, according to research presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, held October 10-12, 2018 in Berlin, Germany.
To address the issue of insufficient real-world data on the safety, tolerability, and efficacy of newer disease modifying therapies, researchers conducted the current non-interventional, multicenter, open-label study to assess the clinical and quality of life outcomes for patients (N=744) with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS) (7.5% CIS and 87.5% RRMS) taking 40 mg of Copaxone (glatiramer acetate) 3 times a week for 2 years. Established endpoints included annual relapse rate, Fatigue Scale Motoric and Cognition (FSMC), Expanded Disability Severity Score (EDSS), quality of life as measured by EQ-5D-5L, information processing as measured by the Symbol Digit Modalities Test (SDMT), and the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Of the 744 patients with multiple sclerosis, 80.8% were female, and the mean disease duration and patient age were 4.5±6.4 years and 39.0±11.1 years, respectively. At treatment outset, 35.5% of patients were treated with 40 mg Copaxone , 48.0% were pre-treated with 20 mg Copaxone , and 15.2% were switched to 40 mg Copaxone from other disease modifying therapies. Participants showed a significant decrease in annual relapse rate, from 0.79±0.70 to 0.36±1.00, and a significant improvement in both patient-reported disability scores and information processing scores (SDMT change from 49.9±14.0 to 52.3±13.4). The EDSS score and other parameters were all stable at data cutoff (baseline EDSS 1.40±1.4 vs 1.60±1.4 at cutoff). A 13.6% rate of mild adverse events was observed, with most being injection site reactions.
Study investigators concluded that the findings confirm the real-world efficacy and safety of Copaxone, "including aspects of cognitive performance and patient reported disability. Ongoing analysis on the complete study cohort and subgroups will provide further evidence on [real-world] effectiveness and parameters of [quality of life] of [glatirimer acetate] 40mg tiw.”
Disclosures: Research support was provided by Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi, and Teva.
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Schulze-Topphoff U, Fendjiare D, Ziemssen T. Multicenter open-label non-interventional study assessing the alteration of activity in ambulatory patients with relapsing forms of MS (RMS) under treatment with COPAXONE® 40 mg tiw - results of an interim analysis of the NIS COPTIVITY. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis 2018. October 10-12, 2018; Berlin, Germany. Poster 890.